Cleared Traditional

Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe

K191490 · Jiangsu Caina Medical Co.,Ltd · General Hospital

Oct 2019

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K191490 is an FDA 510(k) clearance for the Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on October 3, 2019, 120 days after receiving the submission on June 5, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K191490 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2019
Decision Date	October 03, 2019
Days to Decision	120 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF